PMID- 31641633
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2230-8210 (Print)
IS  - 2230-9500 (Electronic)
IS  - 2230-9500 (Linking)
VI  - 23
IP  - 3
DP  - 2019 May-Jun
TI  - Therapeutic Experience of Saxagliptin as First Add-on after Metformin in Indian 
      Type 2 Diabetes Patients: A Non-interventional, Prospective, Observational Study 
      (ONTARGET-INDIA).
PG  - 312-317
LID - 10.4103/ijem.IJEM_56_19 [doi]
AB  - INTRODUCTION: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 
      diabetes mellitus (T2DM) patients but the data available in existing clinical 
      trial programmes on DPP4 inhibitors include limited number of patients from 
      India. Hence, this study attempted to understand usage, efficacy and safety of 
      saxagliptin as first add-on after metformin in Indians with T2DM. METHODOLOGY: It 
      was a multicenter, prospective, non-interventional and observational study 
      planned to enrol T2DM patients who were inadequately controlled with metformin 
      alone and had been recently (i.e., within past 15 days) prescribed saxagliptin as 
      an add-on to metformin. Type 1 diabetes mellitus, use of glucose lowering drugs 
      apart from metformin or saxagliptin, pregnancy, lactation, and medical condition, 
      which could interfere with safe completion of the study were excluded. RESULTS: A 
      total of 1109 participants (658 men and 451 women) with mean +/- SD age of 51.17 +/- 
      11.85 years were enrolled from 50 centres throughout India. Significant reduction 
      was observed in mean +/- SD change of HbA1c as - 0.86% +/- 1.76 from baseline to 
      after 3 months of therapy (P < 0.0001). The quality of life assessed by World 
      Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire was reported 
      to be "good" or "neither good nor bad" by majority of the participants at 
      baseline and after 3 months of treatment. A total of 15 adverse events (AEs) were 
      reported in the study, however, no serious adverse event (SAE) occurred during 
      the study. All AEs were of mild intensity and did not require any intervention. 
      CONCLUSION: Overall, saxagliptin in combination with metformin was generally well 
      tolerated in Indian T2DM patients and new safety event identified is an increased 
      risk of hospitalisation in heart failure patients. This study is also registered 
      on Clinicaltrials.gov (NCT02588859).
CI  - Copyright: (c) 2019 Indian Journal of Endocrinology and Metabolism.
FAU - Kalra, Sanjay
AU  - Kalra S
AD  - Department of Endocrinology, Bharti Research Institute of Diabetes and 
      Endocrinology, Karnal, Haryana, India.
FAU - Bajaj, Sarita
AU  - Bajaj S
AD  - Department of Medicine, Moti Lal Nehru Medical College, Allahabad, Uttar Pradesh, 
      India.
FAU - Unnikrishnan, A G
AU  - Unnikrishnan AG
AD  - Department of Clinical Diabetology and Endocrinology, Chellaram Diabetes 
      Institute, Pune, Maharashtra, India.
FAU - Baruah, Manash P
AU  - Baruah MP
AD  - Department of Endocrinology, Excel Center, Maya Ville, Barthakur Mill Road, 
      Ulubari, Guwahati, Assam, India.
FAU - Sahay, Rakesh
AU  - Sahay R
AD  - Department of Endocrinology, Osmania General Hospital, Hyderabad, Telangana, 
      India.
FAU - Hardik, V
AU  - Hardik V
AD  - Department of Medical Affairs, AstraZeneca Pharma India Ltd, Bengaluru, 
      Karnataka, India.
FAU - Kumar, Amit
AU  - Kumar A
AD  - Department of Medical Affairs, AstraZeneca Pharma India Ltd, Bengaluru, 
      Karnataka, India.
LA  - eng
SI  - ClinicalTrials.gov/NCT02588859
PT  - Journal Article
PL  - India
TA  - Indian J Endocrinol Metab
JT  - Indian journal of endocrinology and metabolism
JID - 101555690
PMC - PMC6683677
OTO - NOTNLM
OT  - DPP4 inhibitors
OT  - Saxagliptin
OT  - type 2 diabetes mellitus
COIS- Hardik V and Amit Kumar are employees of AstraZeneca Pharma India Ltd. Other 
      Authors - No conflict of Interest.
EDAT- 2019/10/24 06:00
MHDA- 2019/10/24 06:01
PMCR- 2019/05/01
CRDT- 2019/10/24 06:00
PHST- 2019/10/24 06:00 [entrez]
PHST- 2019/10/24 06:00 [pubmed]
PHST- 2019/10/24 06:01 [medline]
PHST- 2019/05/01 00:00 [pmc-release]
AID - IJEM-23-312 [pii]
AID - 10.4103/ijem.IJEM_56_19 [doi]
PST - ppublish
SO  - Indian J Endocrinol Metab. 2019 May-Jun;23(3):312-317. doi: 
      10.4103/ijem.IJEM_56_19.